Shiley Neonatal/Pediatric Tracheostomy Tube— 510(k) K182861

Clearance details

Applicant

Covidien

Product code

Code JOH

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2018-10-11

Decision date

2019-03-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Boulder, CO, US

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• K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff2020-06-01
• K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set2019-12-12

• K241486 — Sofsilk Coated Braided Silk Suture2024-12-03
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• K231934 — GIA Stapler with Tri-Staple Technology2023-10-27
• K231240 — MaxTack Motorized Fixation Device2023-09-08
• K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)2023-08-30

Death

42

Injury

1,344

Malfunction

5,608

Other

1

Total

6,995

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →